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Fogarty International Center The Evolving Biomedical Research Ethics Environment in Africa

Ethical principles and benchmarks for multinational clinical research • Collaborative partnership

• Social value • Scientific validity • Fair selection of study population • Favorable risk-benefit ratio • Independent review • Informed consent • Respect for recruited participants & study communities

•The Journal of Infectious Diseases 2004;189:930–7 The Fogarty Mission: A Decade of Bioethics

• Build research ethics capacity in low- & middle-income countries

• Strengthen local input on ethical issues

• Address ethical controversies & dilemmas about research in low- & middle-income countries . E.g. Standards of care in HIV/AIDS research

•Bethesda, Maryland •November 7-9, 1999 Recommendation: Train experts in bioethics Ethics committees recorded for 20 African countries Rwabihama, Girre, Duguet (2010) J. Med. Ethics 36:243-249 Table 1

Year of National Year of Total Committee (Country) continuous board (name, creation committees establishment year) IRB, Witwatersrand 1967 1990 NHREC, 2003 34 (South Africa) IRB, () 1980 2002 NERB, 2003 30 NHRERC, IRB () 1980 2003 6 2002 IRB () 1985 2003 NBC, 2007 6 IRB (Gambia) 1980 2002 Gov/MRC 1 EC () 1995 2002 CNE, 1987 2 EC (Mali) 1994 2001 CNESS, 2002 3 EC (Benin) 1999 2002 CNERS, 2004 2 EC () 2001 2002 CERS, 2002 4 EC () 1998 2002 CNE, 2009 2 EC (Guinea) 1999 2004 CNB, 2009 2 EC (RD Congo) 2003 2005 CNB, 2009 3 EC (Senegal) 2002 2003 CNERS, 2004 1 EC () 2003 2005 CCNB, 2007 1 EC () 1986 2003 CNER, 2003 1 EC () 1979 2001 NEC, 2003 3 IRB () 1996 2002 EGY/NCB 2 IRB () 2000 2004 LPNCBB 4 IRB () 1974 2000 MRCZ 3 IRB () 1982 1999 NCST 4 Constraints hindering operations of ethics review committees (ERCs) Nyika, et al. (2009) J. Med. Ethics 35:189-193

Constraints Number of ERCs* Insufficiency of resources 25/30 Lack of/insufficient expertise on 13/30 ethical review Pressure from researchers 11/30 Lack of active/consistent 11/30 participation of members

Lack of recognition of the 11/30 importance of ERC functions

None or poorly supported by the 10/30 institute Not completely independent 4/30 Pressure from sponsors 3/30 Unequal treatment of applicants in 1/27 review Biased committee members 0/27 The Structure & Function of RECs in Africa Kass, et al. (2007) PLoS Medicine 4(1):e3

REC Funding Number of RECs (n=12) No operating budget 6 Government support 2 Foreign agency 1 Review fees 6 Paid staff 5 Paid members 4 The Structure & Function of RECs in Africa Kass, et al. (2007) PLoS Medicine 4(1):e3

# Protocols 8-12 3 reviewed (n=12) 30-50 3 100-250 5 ~600 1 Review all 7 protocols Review only if 5 funder required Committee Science, Ethics, 4 Focus (n=12) Budget Science & Ethics 4 Science only 2 Ethics only 1 Duration of training of committee members Nyika, et al. (2009) J. Med. Ethics 35:189-193

Number of committee Duration of training members None 132 1 day 13 2–3 days 42 4–7 days 92 >7 days 48 Online training 14 Not known 4 Total 345 Training needs of ERCs in Africa, ranked by respondents Nyika, et al. (2009) J. Med. Ethics 35:189-193

Ranking

Very Quite Not Total Important Training needs important important important institutions

Scientific design issues in intervention trials 27 2 29

Determination of potential risks of vaccine research 25 3 1 29

Determinations to run phases (I,II,III) in a country or community 25 2 1 28 Monitoring and oversight 23 5 1 29 Post-trial access to benefits (e.g, successful intervention) 20 6 1 1 28

The interpretation of preclinical studies 19 7 3 29 The use of placebo in controlled trials 16 9 3 1 29 Assessment of understanding for informed consent 16 10 1 1 28 Assessment of anticipated benefits 15 8 5 1 29 Assessment of cultural sensitivity for informed consent 15 9 3 1 28 Community participation 14 11 3 1 29 Determination of appropriate subject selection in vulnerable 14 8 5 1 28 population

Determination of appropriate subject selection with regard to women 13 6 8 1 28

Incentives for participation 12 10 5 1 28 Social and behavioral studies 12 10 6 1 29 Privacy and confidentiality 11 13 4 1 29

Determination of appropriate subject selection with regard to minors 11 9 6 1 27 Goals of the FIC International Research Ethics Training Program

• Develop socio-culturally relevant, masters level international research ethics curricula including: . Foundational ethics theory . International guidance . LMIC research case studies . Practicum opportunities • Develop LMIC researchers, health professionals & academics in positions to have immediate impact at their institutions with in depth bioethics expertise in order to: . Train others in research ethics . Lead ethical review of research . Contribute to discussion of ethics issues in LMIC research . Develop institutional, national and international ethics guidance

International Research Ethics Training Programs- Masters Level

Africa Asia L. America E. Europe Middle East Johns Hopkins U. Yale- Central FLACSO- Union U./U. U. Maryland-Egypt South Univ. Argentina- Vilnius, Xiangya SoM Einstein U. Lithuania China UMD-U. Ibadan India Centers Vanderbilt/U. CWRU-Russia, Nigeria Med.Research Costa Rica Romania U. KwaZulu-Natal U. Toronto- U. Miami-6 LAC India, Pakistan Inst.

U. Indiana- Moi U. U.Washington- U. Chile Kenya U. Indonesia

UNC-Belgium-U. Aga Khan U, Kinshasa Pakistan

U. Toronto- Nigeria, Ghana

Stellenbosch U- South Africa

Dartmouth/Penn- Muhumbili U-TZ FIC Research Ethics Trainees • ~560 Trainees 2001-2011 •~50% African Trainees The Structure & Function of RECs in Africa Kass, et al. (2007) PLoS Medicine 4(1):e3

Characteristic # RECs (n=12) Trainee Initiated FWA 6 3 Members Trained 10 6 SOPs 9 5 Annual reviews 2 2 Amendment reviews 12 4 Nigeria: Grantee Transforming the Bioethics System

• Results (2005-2010) . 8 Faculty - Masters degrees at JHU, Case Western, U. Toronto . 21 Masters U. Ibadan students . Over 1000 West African researchers-ethics short courses

• Transformed Nigerian National Ethics System . Re-established, chaired & provided member training- National Health Research Ethics Committee, MOH . Drafted Nigerian National Code for Research Ethics . Created web-based research protocol tracking •Clement Adebamowo system . Initiated or strengthened 25 IRBs

• Leadership in Ethics & Genetics in Africa . Member, HAPMAP Consortium . Co-chair, NHGRI Ethics Subcommittee H3 Africa- hosted “Ethics & Genomics Research in Africa” Conference Nov 2011

•University of Ibadan South Africa: From Trainee to Academic Bioethicist

• Masters in Bioethics – U. Toronto 2003

• HIV/AIDS-related Bioethics Activities . Head: Bioethics & Health Law Program, Center for AIDS Program of Research in South Africa (CAPRISA), NIH AIDS Prevention Clinical Trials Network . Columbia University-Southern Africa Fogarty AITRP Scientific Advisory Committee . Member: NIH International Therapeutic DSMB (Africa) . Member: WHO Task Force on Addressing Ethical Issues in TB Control Program Epidemiology & Clinical Research (NCHECR), U. New South Wales, Australia

Jerome Singh • Extensive HIV/AIDS-related Bioethics Publications . Key issues: HIV drug rollout, microbicide trials . High impact factor journals: BMJ, Lancet, Nature, PLoS Med

Research Ethics Updates: RCR Training

• New RCR Training Guidelines . Required section in FIC research training grant applications . Required annual progress reporting

• Supplements for RCR courses in Africa . Essex, Myron/Harvard School of Public Health-Supplement for Responsible Conduct of Research Training at BHP ( Harvard Program) . Kamya, Moses R./Makerere University College of Health Sciences- Supplement for Training in RCR in . Mugyenyi, Peter N./Joint Clinical Research Centre, Uganda- Responsible conduct of research Training at the JCRC (Joint Clinical Research Centre, Uganda) . Murphy, Robert Leo/Northwestern University- Supplement for RCR Training at University of Ibadan (Nigeria)

• RCR training & IRB development at MEPI sites Medical Education Partnership Initiative (MEPI)

•Botswana •Nigeria University of Ibadan • •South Africa University of KwaZulu-Natal •Ghana Stellenbosch University Kwame Nkrumah •Tanzania University of Science and Kilimanjaro Christian Technology Medical Centre •Kenya •Uganda Makerere University • • , College of Medicine •Zimbabwe • Universidade de Eduardo Mondlane

Just the Beginning…..

• New African voices in international research ethics-refocusing the discussion

• Building workable systems in African settings

• Ethics career development

• Sustainability

• Reaching non-Anglophone Africa

• Ethics related to upcoming research in Africa more complex (especially HIV/AIDS) http://www.fic.nih.gov/

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